Hand-held IPL device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

Device Description

The IPL Home Use Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the-counter directly to the end user. The device provides hair reduction using Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The IPL Home Use Hair Removal Device is composed of a hand-held applicator and an external power supply. The spot size (treatment area) in the IPL Home Use Hair Removal Device is 3cm². The device contains a lamp, a skin proximity sensor. If the IPL Home Use Hair Removal Device is not properly applied (in full contact with the skin), the device will not trigger a pulse.

The IPL Home Use Hair Removal Device includes FZ-608, FZ-608G, FZ-100, and FZ-200 four models. Their intended use, performance, structure design and operation are basically identical, with the differences mainly contains product appearance, energy output range and its equipped power supply model. The model difference is embodied in: #1) energy output level of model FZ-608 and FZ-608G has 9 levels, corresponding to an output range of 4.16J~~10J; model FZ-100 has 9 levels, corresponding to an output range of 5.7J~~16.26J, and model FZ-200 has 6 levels, corresponding to an output range of 4.6J~13,5J; #2) the main unit FZ-608 and FZ-608G can be supplied by the power adaptor (model: SHCSP2402000FUS), and the main unit FZ-100 and FZ-200 can only be supplied by the power adaptor (model: SHCY-SP2401500EUS), the adapters have been approved in accordance with IEC 62368-1 and tested with equipment, considering as a part of this ME equipment.

AI/ML Overview

The provided document is a 510(k) summary for an IPL Home Use Hair Removal Device (K230739). It outlines the device's substantial equivalence to predicate devices, focusing on safety and efficacy for over-the-counter (OTC) use.

However, the document does not contain information related to an AI/algorithm-driven device or a study involving ground truth, expert consensus, MRMC studies, or training/test sets for AI models. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the regulatory requirements for a medical device's safety and effectiveness for its intended use, not an AI algorithm's performance against specific metrics established by expert review.

The performance testing mentioned is for the physical device itself (electrical safety, EMC, biocompatibility, and usability/self-selection for OTC use), not for an AI's diagnostic or analytical capabilities.

Therefore, I cannot populate the requested table and answer the specific questions about AI acceptance criteria, ground truth, expert adjudication, or MRMC studies for this device based on the provided text.

The relevant "study" mentioned in the document is a usability study for OTC use, not an AI performance study.

Here's a breakdown of what is available in the document regarding the device's acceptance and testing:

Device Acceptance Criteria and Performance (Based on Usability Study for OTC Use)

The document states that a usability study was conducted to demonstrate that the device is safe and effective for over-the-counter (OTC) use by lay users. The "acceptance criteria" here are implied regulatory requirements for OTC medical devices, specifically regarding user comprehension and safe application.

Acceptance Criterion (Regulatory Implication for OTC Device)	Reported Device Performance (from Usability Testing)
Self-selection: Lay users can determine if they are appropriate candidates for the device based on external labeling.	The study demonstrated that "the lay user can self-select themselves as being appropriate users of this device by the external box labeling."
Safe and Correct Application: Lay users can apply the treatment safely and correctly following the instructions for use.	The study demonstrated that "the lay user can apply the treatment safely and correctly according to the instructions for use."
Comprehension of Labeling: Lay users understand indications, contraindications, warnings, and precautions, and can identify if they are in a contraindicated group.	The study demonstrated that "the lay user can understand all indications, contraindications, warnings and precautions, and be able to identify whether they are within any contraindicated group; and be able to understand the user manual."

Detailed Information Not Applicable to an AI Study:

Since this is a physical medical device (IPL hair removal) and not an AI/algorithm, the following points outlined in your request are not addressed or are not relevant in the provided text:

Sample size for the test set and data provenance:
- Test set sample size: 24 subjects (for the usability/OTC study).
- Data provenance: Not explicitly stated, but likely prospective given it's a usability study involving direct interaction with subjects. Country of origin not specified, but the applicant company is Shenzhen, China.
Number of experts and qualifications for ground truth: Not applicable. Ground truth for an IPL device's usability doesn't involve expert medical image review.
Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert review settings (e.g., radiology). For a usability study, the "adjudication" would be whether users successfully completed tasks or understood information.
MRMC comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
Standalone (algorithm only) performance: Not applicable. There is no AI algorithm.
Type of ground truth used: For the usability study, the "ground truth" would be the successful demonstration of user comprehension and safe device operation, assessed by usability researchers, not medical experts interpreting data like pathology or outcomes.
Sample size for the training set: Not applicable. There is no AI model to train.
How ground truth for the training set was established: Not applicable.

In summary, the provided document details the regulatory clearance of a physical medical device. While it includes "performance testing," this refers to electrical safety, biocompatibility, and OTC usability, not the performance of an AI algorithm against clinical ground truth.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 26, 2023

Shenzhen IONKA Medical Technology Co., Ltd. Yu Yeap Registered Engineer Room 601, No. 3, Jiazitang Second Industrial Zone, Jiazitang Community, Fenghuang Street, Guang Shenzhen, Guangdong 518132 China

Re: K230739

Trade/Device Name: Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHT Dated: March 7, 2023 Received: March 17, 2023

Dear Yu Yeap:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jianting Wang -S

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230739

Device Name

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608G, FZ-100, FZ-200

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

	Grantee Direct Activities (FTA-Wide Section 5310 Program)
	Senior Transportation (FTA-Wide Section 5310 Program)

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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Sponsor: Shenzhen IONKA Medical Technology Co., Ltd. Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, Subject Device: FZ-608G, FZ-100, FZ-200

510(k) Summary K230739

This summary of 510(k) safety and effectiveness information is being submitted in

accordance with the requirements of 21 CFR 807.92.

Submitter Information 1

Company Name: Shenzhen IONKA Medical Technology Co., Ltd. Address: Room 601, No. 3, Jiazitang Second Industrial Zone, Jiazitang Community, Fenghuang Street, Guangming District, Shenzhen, 518132, China Tel.: +86 755 23406031 Fax.: +86 755 23406031 Contact Person (including title): Chen Dongfa (General Manager) E-mail: info@tzwm.com

2 Subject Device Information

Type of 510(k) submission: Traditional 510(k) Device Submission Trade Name: Hand-held IPL device (IPL Home Use Hair Removal Device) Model: FZ-608, FZ-608G, FZ-100, FZ-200 Common Name: Light Based Over-The-Counter Hair Removal Classification Name: Laser surgical instrument for use in general and plastic surgery and indermatology Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 878.4810 Regulation Class: 2

3 Predicate device Information

Legally existing device K221214

Trade Name: Hand-held IPL device (IPL Home Use Hair Removal Device) Model: FZ-608, FZ-608G, FZ-100, FZ-200 Common Name: Powered Light Based Non-Laser Surgical Instrument WithThermal Effect Classification Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Review Panel: General & Plastic Surgery Product Code: ONF Regulation Number: 878.4810 Regulation Class: 2

Reference device K222432

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Trade Name: IPL Hair Removal Device Model: KCA423, KCA437, KCA439 Common Name: Light Based Over-The-Counter Hair Removal Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Review Panel: General & Plastic Surgery Product Code: OHT Regulation Number: 878.4810 Regulation Class: 2

4 Device Description

5 Intended Use

IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

6 Complied Standards

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 complies with the following FDA recognized consensus standards:

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区 Electrical safety test according to AAMI/ANSI ES60601-1, IEC60601-1-11 and IEC 60601-2-83 standards
区 Electromagnetic compatibility test according to IEC 60601-1-2 standard
区 ISO 10993-5:2009/(R) 2014, Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010, Biological Evaluation of Medical Devices Part 10: Tests 区 for Irritation and Skin Sensitization.

Device modification description 7

The only modification of subject device is Intended Use. The device has changed to over-the-counter use. Therefore, the User Manual and Box labelling has been adding corresponding use instructions for lay person user.

8 Performance Testing

As the modification of subject device as above, results in no technological characteristics changes, the tests and data utilized to demonstrate safety and efficacy of the predicate device (legally existing device) are suitable for use in the assessment of the subject devices.

As there have been no changes to the performance of the subject device from the predicate device, this submission leverages performance and electrical testing provided in previous submission.

Meanwhile, self-select and usability testing (OTC Study) was completed in 24 subjects to evaluate device human factors and label comprehension. These study tests demonstrate that the subject device and its labeling can meet the requirement: 1) the lay user can self-select themselves as being appropriate users of this device by the external box labeling, 2) the lay user can apply the treatment safely and correctly according to the instructions for use, and 3) the lay user can understand all indications, contraindications, warnings and precautions, and be able to identify whether they are within any contraindicated group; and be able to understand the user manual.

9 Biocompatibility

All the modified device materials which come in direct contact with the patient skin are biocompatible and identical to the materials used in the predicate device manufacturing. No biocompatibility test report is provided in this submission.

10 Clinical performance

Clinical performance is not deemed necessary.

11 Comparison with predicate device

Compare with predicate device (Hand-held IPL device (IPL Home Use Hair Removal Device) K221214), the subject device is same in design principle, functions, material and the applicable standards. And the intended use of subject device is same to Reference device K222432. The differences between subject device and predicate devices do not raise any new questions of safety or effectiveness.

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Item	Subject Device	Predicate Device	Reference Device
Manufacturer	Shenzhen IONKA Medical Technology Co., Ltd.	Shenzhen IONKA Medical Technology Co., Ltd.	Hunan Guangye BiotechnologyCo., Ltd.
K number	K230739	K221214	K222432
Product Name	Hand-held IPL device (IPL Home Use Hair RemovalDevice)Model: FZ-608, FZ-608G, FZ-100, FZ-200	Hand-held IPL device (IPL Home Use Hair RemovalDevice)Model: FZ-608, FZ-608G, FZ-100, FZ-200	IPL Hair Removal DeviceModel: KCA423, KCA437, KCA439
Regulation &Classification	Classification Name: Laser surgical instrument for use ingeneral and plastic surgery and in dermatologyReview Panel: General & Plastic SurgeryProduct Code: OHTRegulation Number: 878.4810Regulation Class: 2	Classification Name: Powered Light Based Non-LaserSurgical Instrument With Thermal EffectReview Panel: General & Plastic SurgeryProduct Code: ONFRegulation Number: 878.4810Regulation Class: 2	Classification Name: Laser surgicalinstrument for use in general andplastic surgery and in dermatologyReview Panel: General & PlasticSurgeryProduct Code: OHTRegulation Number: 878.4810Regulation Class: 2
Indications forUse	IPL Home Use Hair Removal Device is indicated for theremoval of unwanted hair. The device is also indicatedfor the permanent reduction in hair regrowth, defined asthe long-term, stable reduction in the number of hairsregrowing when measured at 6, 9 and 12 months afterthe completion of a treatment regime.	IPL home use hair removal device is indicated for patientremoval of unwanted hair by using a selectivephotothermal treatment under the direction of aphysician, after training by a healthcare professional.The IPL home use hair removal device is also intendedfor permanent reduction in unwanted hair. Permanenthair reduction is defined as the long-term stablereduction in the number of hairs regrowing whenmeasured at 6. 9. and 12 months after the completion ofa treatment regimen.The device is used for adults with Fitzpatrick skin types I	IPL Hair Removal Device isindicated for the removal ofunwanted hair. The device is alsoindicated for the permanentreduction in hair regrowth, definedas the long-term, stable reduction inthe number of hairs regrowingwhen measured at 6, 9 and 12months after the completion of atreatment regime.

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Item	Subject Device	Predicate Device	Reference Device
	OTC Use	- IV.	OTC Use
Source Energy	Supplied by external adapter	Prescription UseSupplied by external adapter	Supplied by external adapter
Device Type	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light
Wavelength(nm)	510nm~1200nm	510nm~1200nm	475-1200nm
Spot Size	3 cm2	3 cm2	3 cm2
	FZ-608, FZ-608G:Level 1: 4.16JLevel 2: 4.36JLevel 3: 5.1JLevel 4: 6.1JLevel 5: 6.96JLevel 6: 7.96JLevel 7: 8.63JLevel 8: 9.13JLevel 9: 10.0J	FZ-100:Level 1: 5.7JLevel 2: 6.5JLevel 3: 8.06JLevel 4: 9.73JLevel 5: 11.96JLevel 6: 14.1JLevel 7: 15.13JLevel 8: 15.33JLevel 9: 16.26J	FZ-200:Level 1: 4.6JLevel 2: 5.7JLevel 3: 6.63JLevel 4: 8.66JLevel 5: 11.3JLevel 6: 13.5J
Energy outputrange		FZ-608, FZ-608G:Level 1: 4.16JLevel 2: 4.36JLevel 3: 5.1JLevel 4: 6.1JLevel 5: 6.96JLevel 6: 7.96JLevel 7: 8.63JLevel 8: 9.13JLevel 9: 10J	FZ-100:Level 1: 5.7JLevel 2: 6.5JLevel 3: 8.06JLevel 4: 9.73JLevel 5: 11.96JLevel 6: 14.1JLevel 7: 15.13JLevel 8: 15.33JLevel 9: 16.26J	FZ-200:Level 1: 4.6JLevel 2: 5.7JLevel 3: 6.63JLevel 4: 8.66JLevel 5: 11.3JLevel 6: 13.5J	7.35J to 15J








Max. energyoutput density	FZ-608, FZ-608G: 3.33 J/cm²		5 J/cm²
	FZ-100: 5.43 J/cm²	FZ-100: 5.43 J/cm²
	FZ-200: 4.5 J/cm²
Pulse duration	0.5~0.8 ms		7~10ms
Energy medium	Xenon Arc Flashlamp		Xenon Arc Flashlamp
Pulsing Control	Finger switch		Finger switch
Delivery device	Direct illumination to tissue		Direct illumination to tissue

Report by Shenzhen IONKA Medical Technology Co., Ltd.

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Item	Subject Device	Predicate Device	Reference Device
Skin proximitysensor	Sensor fixed in device and can be moved to treatment part	Sensor fixed in device and can be moved to treatment part	Sensor fixed in device and can bemoved to treatment part
Number ofoutput channel	One channel	One channel	One channel
Energy outputlevel	FZ-608, FZ-608G: 9 levelsFZ-100: 9 levelsFZ-200: 6 levels	FZ-608, FZ-608G: 9 levelsFZ-100: 9 levelsFZ-200: 6 levels	7 levels
SoftwareControl?	Yes	Yes	Yes
Structuredesign	Handheld	Handheld	Handheld
Weight	FZ-608, FZ-608G: 1.515kgFZ-100: 1.515kgFZ-200: 1.1kg	FZ-608, FZ-608G: 1.515kgFZ-100: 1.515kgFZ-200: 1.1kg	KCA423: 223gKCA437: 255gKCA439: 235g
Dimensions	FZ-608, FZ-608G: 9814760(mm)FZ-100: 1987144(mm)FZ-200: 2166852(mm)	FZ-608, FZ-608G: 9814760(mm)FZ-100: 1987144(mm)FZ-200: 2166852(mm)	KCA423: 164.8276.440mmKCA437: 16276.743.2mmKCA439: 162.277.942.4mm
Electricalsafety, EMC	AAMI/ANSI ES60601-1IEC 60601-1-11IEC 60601-2-83IEC 60601-1-2	AAMI/ANSI ES60601-1IEC 60601-1-11IEC 60601-2-83IEC 60601-1-2	IEC 60601-1IEC 60601-1-11IEC 60601-2-83IEC 60601-1-2
Biocompatibility	ISO10993-5ISO10993-10	ISO10993-5ISO10993-10	ISO10993-5ISO10993-10

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Although the indication for use of subject device is different to predicate device K221214, but it is only to simplify the statement of the legally existing predicate device and remove the prescription use statement, which is not involved with technical specifications. The revised indication for use of subject device in this submission also had been covered by the indication for use of the legally existing predicate device; which is same to Reference device K222432. And the subject device had been verify by usability study for its OTC use. So the difference does not affect the safety and effectiveness.

12 Summary Prepared Date

7 March. 2023

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.